Risk, Communication, and Strategy

Risk, Communication, and Strategy
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  • Risk Management
  • Yes, and I have scheduled focused discussions to evaluate risk and create mitigation plans.
  • CMC
  • 
  • We have the strategy, but now we need to consider the risks that could derail us. RPM, do you have the template for Risk Register?
  • RPM
  • GRL
  • Regional RL
  • Risk Management
  • CMC
  • 
  • RPM
  • I think the China regulation change needs to be discussed first
  • Here are the risks, let us discuss all together the impact and mitigation strategy
  • when finished will take this to the GPT
  • GRL
  • Regional RL
  • Communication
  • RPM
  • GSM
  • CMC
  • We have a variation to submit, let us review if there are other submissions that need to be done at the same time.
  • One of the impacted markets has a restriction when we can submit, a bundling strategy is crucial!
  • Regional RL
  • Each GRT member identifies risks in their regional/functional area, RPM helps resolving and mitigating issues, GRL is accountable to escalte to GPT
  • Global Regulatory Strategy
  • Now you know the GPT strategy, let's start building the RA strategy, my vision is...
  • GSM
  • We can bring the risks from our stakeholders
  • GRL
  • Let me build the Regional strategy
  • Once all the risks have been identified, the GRT needs to determine the impact and mitigation strategies.
  • Global Regulatory Strategy
  • CMC
  • That risk will have a high impact
  • So for CMC we need to include this in the strategy
  • I have the submission strategy and risks
  • There is a dual line of accountability within the function and within the GRT. Prompt communication is critical for a program, it reduces surprise and enhances efficiencies.
  • Global Regulatory Strategy
  • GSM
  • I have the CMC Strategy
  • CMC
  • I have the region strategy
  • Regional RL
  • GRL brings the GPT strategy to the GRT to start building the Global Regulatory Strategy
  • RPM
  • I can pull everything together so we can understand the critical activities and if there are conflicts.
  • Let me build the CMC strategy
  • CMC
  • Regional RL
  • Each GRT member goes to their stakeholder to create their individual region or functional strategy
  • CMC Stakeholder
  • Dear LOC, We are discussing Strategy for ...
  • Regional RL
  • GRL leads the review of each individual strategy and discussion on how to bring it all together into one Global RA Strategy
  • RPM
  • There are a few scenarios to build based on putting together these individual strategies
  • Agree, we can also challenge more, plus need to document in the GRSP.
  • GRL
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